Functional Lumen Opening With Self-Forming Magnetic Anastomosis
Completed · Not applicable
Conditions studied: Small Bowel Anastomosis
In brief
The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.
Key facts
- Study ID
- NCT06454916
- Run by
- GI Windows, Inc.
- People needed
- 79
- Starts
- 2024-10-04
- Expected to finish
- 2025-10-01
- Last updated by the study team
- 2025-11-13
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 22 years or older at screening
- Candidate for laparoscopic small bowel surgery requiring small bowel anastomosis with cardiac/medical clearance for surgery
- Able to understand and sign informed consent document
- American Society of Anesthesiologists (ASA) score < IV at time of procedure
- Lives, and intends to remain, within a 185-mile radius of study center for the duration of the study
- Able to refrain from smoking during study follow-up period
You may not qualify if…
- Known or suspected allergy to silicone, nickel, titanium or Nitinol
- BMI > 55 kg/m2
- Uncontrolled diabetes (defined as HbA1c >10%)
- Congenital or acquired anomalies of the GI tract, including atresia or malrotation
- Diagnosed with obstructed or perforated colon cancer
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
- Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL
- Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2) or ongoing dialysis
- Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
- Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents
- Active H. pylori infection
- Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
- Contraindication to general anesthesia
- Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
- Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
- Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Where it is running
- Fresno Community Hospital and Medical Center — Clovis, California, United States
- University of Miami — Coral Gables, Florida, United States
- Orlando Health — Orlando, Florida, United States
- Endeavor Health — Evanston, Illinois, United States
- Duke Regional Hospital — Durham, North Carolina, United States
- UT Health Houston — Houston, Texas, United States
- Seger Bariatrics and Metabolism, LLC — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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